Biopharma Process Validation Coordinator

F. Hoffmann-La Roche AG; South San Francisco (CA); On-site; USD 90,000 - 167,000; Full time

Job summary

Genentech is seeking a Project Coordinator to drive PV sample logistics across technical development teams, labs, and contract facilities. You will ensure data integrity, follow regulatory protocols, and support cross-functional collaboration to deliver validated biopharmaceutical processes.

The role requires a Life Sciences degree, 1+ year lab experience, and strong GxP knowledge. Excellent communication and multitasking are essential, with a focus on quality and compliance.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum 1 year laboratory experience in biotech with analytical knowledge.
• Familiarity with GxP documentation and compliance standards.
• Attention to detail and commitment to compliant work.
• Strong written/verbal communication and problem-solving; multitasking ability.

Responsibilities

• Coordinate PV study samples across teams, labs and CMOs.
• Ensure PV study integrity by following protocols and preparing samples.
• Enter data; monitor study status and inform stakeholders.
• Review PV protocols and reports for accuracy and compliance.
• Perform ELISA, PCR, U/HPLC, CE, LC-MS and ICP-MS analyses as per protocols.
• Communicate PV issues at meetings to drive resolution.
• Attend PV/project meetings representing analytical operations.

Skills

Laboratory experience

GxP compliance

Communication skills

Project coordination

Organizational skills

Education

Bachelor's degree in Life Sciences

Tools

ELISA

PCR

U/HPLC

CE

LC-MS

ICP-MS

Job description

Genentech is seeking a Project Coordinator to drive PV sample logistics across technical development teams, labs, and contract facilities. You will ensure data integrity, follow regulatory protocols, and support cross-functional collaboration to deliver validated biopharmaceutical processes.

The role requires a Life Sciences degree, 1+ year lab experience, and strong GxP knowledge. Excellent communication and multitasking are essential, with a focus on quality and compliance.